Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
2
Placebo
Placebo
Interventions
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Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subject must be seeking treatment for cocaine dependence.
* Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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National Institute on Drug Abuse
Principal Investigators
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Liza Gorgon, M.A.
Role: PRINCIPAL_INVESTIGATOR
VA Maryland Health Care System
Locations
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San Francisco General Hosptial
San Francisco, California, United States
Torrance Site
Torrance, California, United States
Denver VA Medical Center
Denver, Colorado, United States
VA Maryland Healthcare System
Baltimore, Maryland, United States
U of Penn School of Medicine
Philadelphia, Pennsylvania, United States
South TX VA Health Care System
San Antonio, Texas, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States
Institute of Resch & Educ Inova Fairfax Hospital
Falls Church, Virginia, United States
Countries
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References
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Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.
Other Identifiers
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NIDA-CSP-1021-1
Identifier Type: -
Identifier Source: org_study_id
NCT00431938
Identifier Type: -
Identifier Source: nct_alias
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